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Serum exosomal miRNA/LncRNA as potential biomarkers for Early detection and monitoring progression of gastric cancer and observation on therapeutic effect of Traditional Chinese Medicine on gastric precancerous lesions

注册号：

Registration number：

ITMCTR2000003958

最近更新日期：

Date of Last Refreshed on：

2020-08-25

注册时间：

Date of Registration：

2020-08-25

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

血清外泌体miRNA/LncRNA联合检测在胃癌早期诊断的应用研究及中药治疗胃癌前病变的疗效观察

Public title：

Serum exosomal miRNA/LncRNA as potential biomarkers for Early detection and monitoring progression of gastric cancer and observation on therapeutic effect of Traditional Chinese Medicine on gastric precancerous lesions

注册题目简写：

English Acronym：

研究课题的正式科学名称：

血清外泌体miRNA/LncRNA联合检测在胃癌早期诊断的应用研究及中药治疗胃癌前病变的疗效观察

Scientific title：

Serum exosomal miRNA/LncRNA as potential biomarkers for Early detection and monitoring progression of gastric cancer and observation on therapeutic effect of Traditional Chinese Medicine on gastric precancerous lesions

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

ChiCTR2000036857 ; ChiMCTR2000003958

申请注册联系人：

闫秀丽

研究负责人：

闫秀丽

Applicant：

Xiuli Yan

Study leader：

Xiuli Yan

申请注册联系人电话：

Applicant telephone：

+86 13764993708

研究负责人电话：

Study leader's telephone：

+86 13764993708

申请注册联系人传真 ：

Applicant Fax：

+86 021-65162625

研究负责人传真：

Study leader's fax：

+86 021-65162625

申请注册联系人电子邮件：

Applicant E-mail：

yxl9999@126.com

研究负责人电子邮件：

Study leader's E-mail：

yxl9999@126.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

上海市虹口区甘河路110号1号楼C134室

研究负责人通讯地址：

上海市虹口区甘河路110号1号楼C134室

Applicant address：

110 Ganhe Road, Hongkou District, Shanghai, China

Study leader's address：

110 Ganhe Road, Hongkou District, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

上海中医药大学附属岳阳中西医结合医院

Applicant's institution：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

KYSKSB2020-120

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2020/8/21 0:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

Congquan Yin

伦理委员会联系地址：

上海市虹口区甘河路110号

Contact Address of the ethic committee：

110 Ganhe Road, Hongkou District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 021-65161782-8122

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市虹口区甘河路110号1号楼C134室

Primary sponsor's address：

110 Ganhe Road, Hongkou District, Shanghai, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

具体地址：

上海市虹口区甘河路110号

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Address：

110 Ganhe Road, Hongkou District, Shanghai

经费或物资来源：

上海申康医院发展中心

Source(s) of funding：

Shanghai Hospital Development Center

研究疾病：

胃癌及胃癌前病变

研究疾病代码：

Target disease：

Gastric cancer and precancerous lesions

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

本研究的最终目标是确定循环的外泌体miRNA和LncRNA是否可以作为早期检测和监测胃癌进展的高度特异性和敏感性生物标志物，并为药物的疗效提供新的指标。 胃癌是我国致死率最高的癌症，早期诊断和监测是降低胃癌致死率的关键。恶性肿瘤细胞分泌的外泌体会携带肿瘤细胞特征性miRNA和LncRNA进入循环中，成为非侵入性癌症早期诊断的理想标志物。本研究旨在鉴定血清中胃癌组织细胞来源的外泌体miRNA和LncRNA作为胃癌早期诊断和监测的生物标志物，从而在早期阶段提高胃癌诊断的特异性和敏感性。课题组基于TCGA、GEO和外泌体数据库的生物信息学分析并结合miRNA和LncRNA被分选到外泌体的机制，筛选出了在胃癌组织较正常组织呈高表达并与患者预后密切相关的候选miRNA和LncRNA；已收集258例未经治疗的原发性胃癌患者和160例健康者的血清样本。课题组后继将提取健康者、胃癌前病变患者和胃癌患者血清中外泌体，运用实时定量PCR技术检测和确认外泌体中有临床诊断价值的miRNA和LncRNA并构建诊断模型；应用细胞实验揭示循环miRNA和LncRNA的细胞来源及在胃癌细胞的功能；最后观察临床有效药物藿苏养胃口服液和胃复春治疗胃癌前病变患者的临床疗效，及对血清中有诊断价值的miRNA和LncRNA表达的影响。本课题的顺利实施将揭示循环外泌体miRNA/LncRNA可以作为无创生物标志物，用于检测早期胃癌和监测胃癌进展，循环外泌体miRNA/LncRNA联合检测与内窥镜检查相结合可以提高胃癌的早期诊断率，并为药物疗效评价提供新的指标。

Objectives of Study：

The ultimate goal of this study is to determine whether circulating exosomal miRNA and LncRNA can be used as highly specific and sensitive biomarkers for early detection and monitoring of gastric cancer progression, and to provide new indicators for the efficacy of drugs. Gastric cancer is the cancer with the highest mortality rate in my country, and early diagnosis and monitoring are the key to reducing the mortality rate of gastric cancer. Exosomes secreted by malignant tumor cells will carry tumor cell characteristic miRNA and LncRNA into the circulation, becoming an ideal marker for early diagnosis of non-invasive cancer. This study aims to identify the exosomal miRNA and LncRNA derived from gastric cancer tissue cells in serum as biomarkers for early diagnosis and monitoring of gastric cancer, so as to improve the specificity and sensitivity of gastric cancer diagnosis in the early stage. Based on the bioinformatics analysis of TCGA, GEO, and exosome databases, and combined with the mechanism by which miRNA and LncRNA are sorted into exosomes, the research team screened out gastric cancer tissues that are more highly expressed than normal tissues and are closely related to the prognosis of patients. Candidate miRNA and LncRNA; Serum samples of 258 untreated patients with primary gastric cancer and 160 healthy individuals have been collected. The research team will then extract exosomes from the serum of healthy individuals, patients with gastric precancerous lesions and patients with gastric cancer, use real-time quantitative PCR technology to detect and confirm miRNA and LncRNA in exosomes with clinical diagnostic value, and build diagnostic models; use cell experiments to reveal circulation The cell source of miRNA and LncRNA and their function in gastric cancer cells; finally, observe the clinical efficacy of clinically effective drugs Huosuyangwei Oral Liquid and Weifuchun in the treatment of patients with gastric precancerous lesions, and the expression of miRNA and LncRNA with diagnostic value in serum influences. The successful implementation of this project will reveal that circulating exosomes miRNA/LncRNA can be used as non-invasive biomarkers to detect early gastric cancer and monitor the progress of gastric cancer. The combination of circulating exosomal miRNA/LncRNA detection and endoscopy can improve gastric cancer Early diagnosis rate, and provide new indicators for drug efficacy evaluation.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

120名胃癌前病变病例来自于在上海中医药大学附属岳阳中西医结合医院消化内科门诊的病人。诊断参照《中国慢性胃炎共识意见》中的相关标准（中华医学会消化病学分会．中国慢性胃炎共识意见(2017年, 上海).胃肠病学, 2017, 22(11):670-687）。 ①所有纳入者必须符合上述诊断标准，即慢性萎缩性胃炎尤其是伴有中-重度肠化生或异型增生（上皮内瘤变）患者； ②年龄20-75岁； ③签署知情同意书。

Inclusion criteria

120 cases came from outpatients and inpatients in the Department of Gastroenterology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine. Diagnosis refers to the relevant standards in the "Chinese Consensus on Chronic Gastritis" (Chinese Medical Association Gastroenterology Branch. China Chronic Gastritis Consensus (2017, Shanghai). Gastroenterology, 2017, 22(11):670-687). 1. All participants must meet the above diagnostic criteria, that is, chronic atrophic gastritis, especially patients with moderate to severe intestinal metaplasia or dysplasia (intraepithelial neoplasia); 2. Aged 20 to 75 years old; 3. signed informed consent.

排除标准：

①病理检查证实已出现癌变者； ②合并重要脏器病变者，难以完成临床试验方案； ③合并有情绪障碍、认知障碍； ④妊娠期、哺乳期者。

Exclusion criteria：

1. Patients confirmed by pathological examination to have cancer; 2. Patients with major organ diseases, it is difficult to complete the clinical trial program; 3. Patients with mood disorders and cognitive disorders; 4. Patients during pregnancy and lactation.

研究实施时间：

Study execute time：

从From 2020-10-01

至To      2022-09-30

征募观察对象时间：

Recruiting time：

从From 2020-10-01

至To      1990-01-01

干预措施：

Interventions：

组别：

治疗组

样本量：

60

Group：

Experimental group

Sample size：

干预措施：

藿苏养胃口服液

干预措施代码：

Intervention：

Huosu Yangwei oral liquid

Intervention code：

组别：

对照组

样本量：

60

Group：

Control group

Sample size：

干预措施：

胃复春片

干预措施代码：

Intervention：

WeiFuChun tablet

Intervention code：

样本总量 Total sample size ： 120

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

单位级别：

三级甲等

Institution/hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

肾功能

指标类型：

附加指标

Outcome：

Kidney function

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血清外泌体miRNA/LncRNA

指标类型：

主要指标

Outcome：

Serum exosomal miRNA/LncRNA

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病理检查

指标类型：

主要指标

Outcome：

Pathology

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肝功能

指标类型：

附加指标

Outcome：

Liver function

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

电子胃镜

指标类型：

主要指标

Outcome：

Electronic gastroscope

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胃蛋白酶原

指标类型：

主要指标

Outcome：

Pepsinogen

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心电图

指标类型：

附加指标

Outcome：

Electrocardiogram

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后保存

说明

Fate of sample 

Preservation after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 岁
Min age years
最大 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

胃癌前病变患者120例，入组前均已签署知情同意书，签署前告知受试者研究的相关信息和研究过程，填写CRF表，研究者按照随机数字表分为治疗组60例，对照组60例。

Randomization Procedure (please state who generates the random number sequence and by what method)：

120 patients with gastric precancerous lesions had signed the informed consent form before enrollment, informed the subjects of the relevant research information and research process before signing, and filled in the CRF form. 60 cases in the treatment group and 60 cases in the control group.

盲法：

未说明

Blinding：

Not stated

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

2023-3-29，公开原始数据于本平台。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

2023-3-29, publish the original data on this platform.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

A standard data collection and management system include a CRF and an electronic data capture.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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